MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for BOX OF SPECIMEN COLLECTION KITS, MULTITEST SWAB PRD-03546 manufactured by Hologic, Inc..
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(b)(6) was contacted by a doctors surgery at the (b)(6). The doctors surgery reported their patient told them that the tube containing the transport media had been left open by the patient and in the same room as her child. When she came back in the room the tube was knocked over and the fluid was spilled on the side next to the container. The tube only contained transport media, and did not contain sample at that time. The patient thought that her child had knocked over the container and was unsure if the child swallowed any liquid. Medical attention provided. No details reported. No follow up treatment information was provided. Hologic provided sds to reporter, as requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00001 |
| MDR Report Key | 6234824 |
| Date Received | 2017-01-09 |
| Date of Report | 2017-01-09 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2017-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BOX OF SPECIMEN COLLECTION KITS, MULTITEST SWAB |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LIO |
| Date Received | 2017-01-09 |
| Catalog Number | PRD-03546 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-09 |